1. Field of the Invention
The present invention relates to a container and method for home testing and diagnosis of infectious diseases, including HIV and hepatitis C, and more particularly to a container that provides sequential access to the articles or goods contained therein to increase testing compliance and correct usage.
2. Description of the Related Art
Self testing kits for various diseases and/or physiological conditions have increased in popularity. In such kits, the user typically obtains a sample of physiological fluid, for example, blood, urine, saliva, etc., and introduces the sample into a home test system that produces a coded pattern indicative of the presence or absence of the disease or condition.
A problem with the emergence of these over-the-counter (OTC) medical devices, self delivery drug devices, as well as other testing products, is that they require detailed use and instructions to be accurately used by the user. Although the manufacturer may provide carefully written instructions and warnings, users often access and use the device or product housed within the container without ever considering such instructions. As a result, the effectiveness of the test may be reduced when the test is incorrectly administered by a consumer as opposed to a trained professional. Effective and correct use of the test can determine whether ever increasing performance specifications required by the FDA are successfully met.
Furthermore, the installation and use instructions for such products and devices are often complex and presented on multiple pages in pamphlet form. It is easy for the user to ignore or lose instructions provided in this form.
More often, OTC medical devices, self delivery drug devices and other medical testing devices have multiple components that need to be administered, assembled, or installed in a particular order and performance may be highly dependent on timing parameters. Despite detailed instructions and indicia, users often misunderstand the sequence or timing requirements, resulting in improper assembly, installation, or use. As a result, the products are often rendered ineffective. U.S. Pat. No. 6,382,205, for example, discloses a packaged medical device complete with instructions for use. However, the user has the ability to access the different components independent of the instructions, making it easy for the user to remove the components without ever reading the instructions.
Accordingly, there is a need for a method and/or container or package for testing devices and products that compels or encourages the user to read detailed use-instructions prior to using, assembling, or interpreting the devices/and or products.
There is a further need to provide an improved method of packaging such testing devices and components, whereby the user must first access the instructions or other vital information before the user can access the device or product.
There is also a need for a method and/or container that provides information on how the user can access interactive guidance or counseling regarding that tells the user how to use the test, interpret the results, and/or take appropriate steps for prevention or treatment after administering the test.